About the Author

Claudio Carini, MD, PhD, FRCPath, has been involved in the
application of biomarkers in precision medicine for the past 18
years. He is currently appointed as H. Faculty in the Department of
Cancer and Pharmaceutical Sciences, Faculty of Life Sciences &
Medicine at King's College, School of Medicine, London. He is a
member of the F-NIH Biomarkers Consortium Steering Committees for
Cancer, Inflammation & Immunity, and Neuroscience. He is also a
senior member of the Scientific Advisory Boards for several
biotechnology companies and a member of the New York Academy of
Sciences. Claudio was formerly the Global Head of Clinical
Immunology and Biomarkers at Pfizer Inc., where he led precision
medicine activities across multiple therapeutic areas and
facilitated international collaborations with prestigious academic
institutions. He also held senior roles in pharmaceutical companies
(Wyeth, Novartis, and Roche) and faculty positions at Harvard and
Johns Hopkins Medical School. He is a strong believer of open
innovation networks, and in his roles he has been collaborating
extensively with different stakeholders to speed up the clinical
application of scientific research through public-private
partnerships. He has served in several national and international
scientific boards: F-NIH Inflammation/Immunity; MRC, Inflammation/
Immunology Initiative-Rheumatoid Arthritis Consortium; MRC,
"Stratified Medicine, SLE Consortium; IMI, ABIRISK, EU/EFPIA"; The
PML Consortium. Claudio has over 200 publications in national and
international peer-reviewed journals. He has also co-edited three
books in the field of Biomarkers and Precision Medicine: Biomarkers
in Drug Development: A Handbook of Practice Application and
Strategy, (2010), Clinical and Statistical Considerations in
Personalized Medicine, (2014), and Handbook of Biomarkers &
Precision Medicine (2019 in press). Mark D. Fidock, PhD, is Vice
President of Precision Medicine Laboratories within the IMED
Biotech Unit, AstraZeneca, Cambridge, UK. He received his PhD from
the University of East Anglia, UK, in Molecular Pharmacology. Mark
is a trained molecular biologist/pharmacologist and gained
extensive experience in drug development early in his career while
at Pfizer Ltd, Sandwich, UK. He supported the development and
approval of four new therapies and provided leadership for the
Biomarker and Translational Medicine activities across multiple
therapeutic areas. Mark joined AstraZeneca in 2013, appointed to
the role of Head of Precision Medicine Laboratories and a member of
the Precision Medicine and Genomics Leadership Team. He has overall
accountability for all clinical testing activities that enables
diagnostic development and regulatory approval. Mark leads a global
multidisciplinary team providing strategy and direction in the
development of Companion Diagnostic tests linked to targeted
therapeutics across Oncology; Respiratory; and Cardiovascular,
Renal, & Metabolism. These laboratory tests are deployed across
both early- and late-phase clinical trials with the intent for
global regulatory approval. By 2019 Mark had achieved >25
regulatory approved companion diagnostic tests across 3 major
markets (USA, EU and Japan) linked to 4 AstraZeneca targeted
therapies. Mark has a passion for innovative diagnostic science,
driving research such as the use of artificial intelligence across
tissue and molecular diagnostics to enable approaches that improve
clinical testing outcomes with the ambition to change clinical care
pathways. Mark has published more than 30 peer-reviewed articles in
scientific journals and an active editor of the Journal of
Precision Medicine. As an internationally recognized expert in
Precision Medicine he holds an honorary position at the University
of Cambridge and a member of the Institute of Translational and
Stratified Medicine, Plymouth, scientific advisory board. Alain J.
van Gool, PhD, is a professor of Personalized Healthcare and heads
the Translational Metabolic Laboratory at the Radboud university
medical center, Nijmegen Netherlands, with a strong passion in the
application of biomarkers in translational medicine and
personalized healthcare. Being trained as biochemist and molecular
biologist, Alain worked at pharmaceutical industry (Organon,
Schering-Plough, MSD), academia, applied research institutes, and
university medical centers in EU, USA, and Singapore. He has been
leading technology-based laboratories, cross-functional expert
teams, therapeutic project teams, and public-private consortia,
many of which were focused on the discovery, development, and
implementation of translational biomarkers in a variety of
therapeutic areas. His technical expertise resides most strongly in
molecular profiling through x-omics, analytical biomarker
development, and applications in translational scientific research.
Alain is a strong believer of public-private partnerships and
thrives to work with specialists to translate research findings to
applications. With that background, he currently also acts as
Strategic Advisor to the Executive Board of Radboudumc, coordinates
the Radboudumc Technology Centers, is Scientific Lead Technologies
of DTL (the Dutch Techcenter for Life Sciences), is Chair Biomarker
Platform of EATRIS (the European infrastructure for Translational
Medicine), is co-initiator of Health-RI (the Netherlands
Personalized Medicine and Health Research Infrastructure), and
project leader and PI of the Netherlands X-omics Initiative, thus
contributing to the organization and coordination of local,
national, and European technology infrastructures. Alain has
published 40 peer-reviewed articles in scientific journals and is a
frequently invited keynote speaker at scientific conferences and
public events. Complementing his daily work, he enjoys contributing
as translational biomarker scientist to editorial boards of
scientific journals, funding agencies, and scientific advisory
boards of start-up enterpreneurs, multinational companies,
diagnostic organizations, public-private consortia, and conference
organizers.

Reviews

"This handbook is hardcover and was published at CRC Press / Taylor
and Francis Group in 2019. From the first time I opened it, I could
notice that the printing and quality of paper is exceptional. The
handbook has 631 pages and very nicely coloured figures, schemes
and drawings, that are very easily understandable and very helpful
in processing the text of the handbook. The field of biomarkers is
approached in this book in a scholastic manner, starting from the
first discovery and use of biomarkers to the regulatory approaches
in the field of precision medicine, passing from preclinical
studies, translational medicine, clinical trials, and
implementation in practice. Several case-studies are presented
related to HIV diagnosis, infertility, coagulation, BRCA
identification, but also case-studies related to biomarker-based
clinical trials... This handbook is complete, exact, succinct and
unique, and gathers information from different perspectives, useful
to different players from the field of biomarkers in precision
medicine, making it a an excellent tool for learning. First of all,
I would recommend this handbook to researchers from the medical and
connected fields. It could help the development of this engaging
field of personalized care due to highly accurate and relevant data
presented by the authors. Secondly, I would recommend it to medical
doctors from all specialties since it offers a deep and
comprehensive approach into a field that only a few decades ago was
hardly recognized and since the practice of medicine in most
specialties during the following years will, for sure, include a
personalized approach to
patients. Both these addressees, researchers and medical
practitioners, can make a difference. Least but not last, I would
say that even residents and medical students would benefit from the
comprehensive approach that this book provides."
- Costela Serban, ISCB December 2019